CLSI POCT9 P : 1ED 2009
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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SELECTION CRITERIA FOR POINT-OF-CARE TESTING DEVICES
30-04-2010
12-01-2013
Abstract
Committee Membership
Foreword
1 Scope
2 Introduction
3 Standard Precautions
4 Terminology
5 Why Consider Point-of -Care Testing
6 Clinical Needs Assessment
7 Operational Needs Assessment
8 Point-of-Care Testing System Selection
9 Regulatory and Accreditation Requirements
10 Implementation Checklist
11 Continuing Process for Quality Point-of-Care Testing
References
Appendix A - Determination of Needs for a New Point-of-Care
testing System
Appendix B - Clinical Needs Assessment Comparison Worksheet
Appendix C - Items to consider When Comparing Point-of-Care
Testing System Specifications
Appendix D - Cost Assessment Worksheets
Appendix E - Point-of-Care Testing Personnel Evaluation
Appendix F - Preimplementation Checklist
The Quality Management system Approach
Related CLSI Reference Materials
Gives guidance on selection of point-of-care testing devices based on the patient care setting and clinical needs.
DocumentType |
Proposed Guideline
|
PublisherName |
Clinical Laboratory Standards Institute
|
Status |
Superseded
|
SupersededBy |
CLSI EP14 A2 : 2ED 2005 | EVALUATION OF MATRIX EFFECTS |
CLSI POCT4 A2 : 2ED 2006 | POINT-OF-CARE IN VITRO DIAGNOSTIC (IVD) TESTING |
CLSI EP21 A : 1ED 2003 | ESTIMATION OF TOTAL ANALYTICAL ERROR FOR CLINICAL LABORATORY METHODS |
CLSI EP5 A2 : 2ED 2004 | EVALUATION OF PRECISION PERFORMANCE OF QUANTITATIVE MEASUREMENT METHODS |
CLSI GP11 A : 1ED 98 | BASIC COST ACCOUNTING FOR CLINICAL SERVICES |
CLSI EP6 A : 1ED 2003 | EVALUATION OF THE LINEARITY OF QUANTITATIVE MEASUREMENT PROCEDURES - A STATISTICAL APPROACH |
CLSI M29 A3 : 3ED 2005 | ACQUIRED INFECTIONS; APPROVED GUIDELINE |
CLSI C3 A2 : 1991 | PREPARATION AND TESTING OF REAGENT WATER IN THE CLINICAL LABORATORY |
CLSI EP15 A2 : 2ED 2006 | USER VERIFICATION OF PERFORMANCE FOR PRECISION AND TRUENESS |
CLSI EP9 A2 : 2ED 2002 | METHOD COMPARISON AND BIAS ESTIMATION USING PATIENT SAMPLES |
CLSI GP2 A5 : 5ED 2006 | LABORATORY DOCUMENTS - DEVELOPMENT AND CONTROL |
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